Monday, November 04, 2013

FDA Lose Sight With Glaxo's Potiga

The Food and Drug Administration (FDA), the US drugs regulator, have slammed a black box warning on another of Glaxo's drugs, this time it warns that their anti-seizure medication, Potiga (ezogabine), is linked to eye damage and skin problem side effects. [1]

A Black Box Warning, is the strongest warning that can be placed on a prescription medication. The warning will alert patients and doctors to the risk of severe retinal pigment changes that can lead to blindness. The label will also warn about a risk of skin discoloration, particularly of hands, toes and lips, among users of Potiga.

Potiga was approved by the European Medicines Agency under the trade name Trobalt on March 28, 2011, and by the FDA, under the trade name Potiga, on June 10, 2010.

Earlier this year the British drugs regulator, the MHRA, issued a warning to healthcare professionals in the UK. They wrote:

Pigment changes (ie, discolouration) of ocular tissue, including the retina, have been reported in two long-term clinical studies of retigabine and a compassionate use programme. These studies also observed blue-grey discolouration of the nails, lips, or skin. These reports are considered to be very common (ie, occurring in ≥1/10 patients) after prolonged retigabine treatment.From these studies, 55 patients had eye examination up to May 2, 2013; baseline eye assessments were not done. 21 patients had pigment changes in ocular tissue—15 of which involved the retina. Five patients had visual acuity worse than 20/20.

GlaxoSmithKline, who developed Potiga with Valeant Pharmaceuticals, proudly boast on their website that they are "a global healthcare company that is committed to helping people to do more, feel better and live longer."